Per and Polyfluoroalkyl Substances (PFAS)

Per- and polyfluoroalkyl substances (PFAS) are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are resistant to grease, oil, water and heat. For this reason, beginning in the 1940’s, PFAS have been used in a variety of applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints, and fire-fighting foams. In addition, certain PFAS are authorized by the FDA for limited use in cookware, food packaging and processing.

The widespread use of PFAS and their ability to remain intact in the environment means that over time PFAS levels from past and current uses can result in increasing levels of environmental contamination. Accumulation of certain PFAS has also been shown to occur in humans and animals, as found through blood tests. While the science surrounding potential health effects of PFAS is developing, current evidence suggests that the bioaccumulation of certain PFAS may cause serious health conditions.

To advance knowledge on potential exposure from food and the associated health risks of PFAS, the FDA is working with the U.S. Environmental Protection Agency, the U.S. Department of Agriculture, the National Institutes of Health, the Centers for Disease Control and Prevention, and the U.S. Department of Defense, as well as local and state governments and national organizations.

Continued research and additional analyses of foods will help inform FDA efforts to identify and prioritize activities to reduce PFAS in human and animal food. This research will also increase the agency’s ability to detect, evaluate, and respond more quickly to potential contamination issues involving food. To lead this effort, in 2019, the FDA formed an internal workgroup and is committed to engaging with consumers, industry, and other federal, state, and local government partners in this process.

PFAS can enter the food chain through environmental contamination, such as when crops are grown in contaminated soil or water is used from a contaminated source. Typically, contaminated groundwater and soil is limited to a specific geographic area, for example, near an industrial facility where PFAS were produced or used to manufacture other products, or an oil refinery, airfield or other location at which PFAS-containing products were used for firefighting.

Measuring PFAS concentrations in food, estimating dietary exposure, and determining the associated health effects is an emerging area of science. FDA scientists are at the forefront of developing new and more sensitive testing methods to measure low levels of PFAS in foods. In October 2019, the FDA made available the first single-lab validated method for testing for certain specific PFAS in a diverse group of foods. While the FDA continues to lead national efforts to estimate overall dietary exposure to PFAS, this is an important step in furthering collaboration between the FDA and states in assessing the safety of human and animal food from specific areas potentially affected by environmental contamination.

It is important to note that PFAS contamination in the environment (air, water, and soil) where food is grown does not necessarily mean the food itself will contain detectable PFAS. This is because the amount of PFAS taken up by foods depends on many factors, including the specific type of PFAS and characteristics of the food. Limited FDA testing for certain PFAS chemicals has found that most foods have no or very low levels of PFAS.

When there is evidence of PFAS in food, the FDA conducts a safety assessment using the best available current science to evaluate whether the levels present a possible human health concern. Throughout this process, the FDA works closely with our federal partners as well as with state and local officials to assess each situation and take appropriate next steps.

The FDA safety assessment method used for chemical contaminants considers how much people eat of the specific food and the toxicity of the specific contaminant(s) to characterize the human health concern. When analyzing food that may contain PFAS because of environmental contamination, the FDA has used the Environmental Protection Agency’s reference doses (RfD) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), of 0.02 μg/kg bw/day as an appropriate toxicity reference value. This focus on PFOA and PFOS is because they are the two types of PFAS that have been produced in the largest quantities in the U.S. and are among the most studied.

Dairy, 2018-2019: Samples were collected from two dairy farms (Farm A & Farm B) with PFAS contamination of groundwater. Based on the best available current science, the FDA has no indication that the levels of PFAS found in the limited sampling of milk from Farm B and cheese from Farm A present a human health concern. Milk samples from Farm A had levels of PFAS that were determined to be a potential human health concern and all milk from that farm was discarded and did not enter the food supply.

Produce, 2018: Produce samples were analyzed from an area with PFAS environmental contamination, in addition to 1 sample purchased outside of the area as a control. Sixteen of the 20 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that these substances, at the levels found in the limited sampling, present a human health concern.

Cranberries, 2016: Cranberry samples analyzed from a bog containing water with PFAS contamination. None of the 42 cranberry samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions.

Produce, meat, dairy, and grain products, 2019: In 2019, samples that had been collected as part of the FY2018 Total Diet Study were analyzed for 16 types of PFAS chemicals. The sample sizes are limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that the PFAS at the levels found in the limited sampling present a human health concern.

Bottled Water, 2016: Samples of domestic and imported carbonated and non-carbonated bottled water were collected at retail locations in the Washington, D.C. metropolitan area and analyzed for PFAS. The samples included: purified, artesian, spring, mineral, and carbonated waters. None of the 30 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions.

Seafood, 2013: Fish and shellfish samples from 13 species of fresh and saltwater fish from across the country were analyzed for PFAS. Eleven of the 46 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that these substances at the levels found in the limited sampling present a human health concern.

Milk, 2012: Raw and retail milks were sampled from across the country and analyzed for PFAS. One of the 12 raw milk samples and none of the 49 retail milk samples had detectable levels of PFAS. The one raw milk sample with detectable PFAS was obtained from a dairy farm that had applied PFAS containing biosolids to its fields.

To ensure that food contact substances used in packaging, cookware, and food processing equipment are safe for their intended use, the FDA conducts a rigorous review of scientific data prior to their authorization. Prior to 2000, the FDA authorized the use of food contact substances through the food additive petition process, which resulted in a regulation establishing safe conditions of use in Title 21 of the Code of Federal Regulations. Since 2000, the FDA authorizes the use of food contact substances through the Food Contact Notification (FCN) program. The Inventory of Effective Food Contact Substance (FCS) Notifications is a publicly available database of all uses of food contact substances authorized through the FCN program.

Certain PFAS are currently authorized for use in specific applications related to their non-stick and grease, oil, and water-resistant properties. Whether these PFAS migrate to food depends on the molecular structure of the PFAS and the conditions of use. For example, the PFAS used in non-stick coatings on cookware and sealing gaskets for food processing equipment do not migrate to food. However, PFAS used to make oil- and water-resistant coatings on paper food packaging have the potential to migrate to food. The specific authorized uses for PFAS in food packaging take into consideration this potential for migration and these authorized uses are limited to ensure safe levels of exposure.

The FDA reviews updated scientific information on food contact substances as it becomes available. The agency can revoke food contact authorizations when scientific data demonstrate that the authorized uses of a food contact substance are no longer safe. In addition, the FDA can also work with industry to remove food contact substances from the market through voluntary agreements.

For example, in 2011, the FDA obtained voluntary agreements with the manufacturers of certain “long-chain” PFAS compounds authorized under food contact notifications to remove those substances from food contact applications. “Long-chain” and “short-chain” refer to the number of carbon atoms in the molecular structure of a subset of PFAS. In 2016, the FDA revoked the regulations that authorized the remaining uses of these long-chain PFAS in food packaging.

Newer studies suggest that “short-chain” PFAS (i.e., carbon chain length is less than 8 atoms long), may also pose a risk to human health. To better understand the potential health effects of these PFAS the FDA is collaborating with the National Toxicology Program. This, along with emerging information from the U.S Environmental Protection Agency, the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry will inform any future action on the authorizations for the short-chain PFAS in the manufacturing of components for use in food packaging.